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Chlorpromazine Hydrochloride 25 mg/mL Injection, 25 vials — NDC 70771-1778-07 package photo

Chlorpromazine Hydrochloride 25 mg/mL Injection, 25 vials

by Zydus Lifesciences Limited · 25 VIAL in 1 CARTON (70771-1778-7) / 1 mL in 1 VIAL (70771-1778-1)
NDC 70771-1778-07
🏷️ FDA NDC (as labeled) 70771-1778-7 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Chlorpromazine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0635-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0634-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0631-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0638-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0636-2025
Class II · Sep 3, 2025 — CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0633-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70771-1778-7
Product NDC 70771-1778
11-digit billing NDC 70771177807
RxCUI 1730076, 1730078
UNII 9WP59609J6
UPC 0370710184971
Application # ANDA217275
SPL Set ID d37a4c21-b503-4791-a4d0-2ccc8891d88e
Established class (EPC) Phenothiazine
Chemical class Phenothiazines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-29
Route INTRAMUSCULAR
Dosage form INJECTION
Substance CHLORPROMAZINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 70771-1778-7 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70771-1778-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Phenothiazine class.

Pharmacologic class Phenothiazine
Drug family (ATC) Phenothiazines with aliphatic side-chain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA217275 (ANDA)
Labeler code70771
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio717 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Chlorpromazine treats a range of conditions. Most commonly, it's prescribed for schizophrenia and other psychotic disorders, or to control the manic phase of manic-depressive illne...
  • What exactly is chlorpromazine used for?
  • It depends on what it's being used for. For psychotic disorders, full improvement can take weeks — or even months — so don't be discouraged if you don't feel a dramatic change righ...
  • Drowsiness is the most common early side effect, and it usually gets better after the first week or two. You might also notice dry mouth, nasal congestion, constipation, or lighthe...
📖 Read our full Chlorpromazine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Chlorpromazine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Chlorpromazine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 2 mg / 1 mL UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • 6 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 1 mg / 1 mL UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • 1 mg / 1 mL UNII VTK01UQK3G
    Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlorpromazine Hydrochloride 25 mg/mL 00404-9836-01 Henry 1 ampule — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 00641-1397-35 Hikma 25 ampules — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 31722-0366-32 Camber 25 vials — AP FDA listed —
Chlorpromazine Hci 25 mg/mL 43598-0140-25 Dr. 25 vials — AP FDA listed —
Chlorpromazine Hci 25 mg/mL 51662-1406-01 HF 2 ml — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 55150-0318-25 Eugia 25 ampules — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 65219-0128-01 Fresenius 25 vials — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 66794-0249-42 Piramal 25 vials — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 68083-0533-25 Gland 25 vials — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 70710-1849-07 Zydus 25 vials — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mLthis 70771-1778-07 Zydus 25 vials — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 72205-0190-25 Novadoz 25 vials — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 73043-0048-25 Devatis, 25 ampules — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 70710-1850-07 Zydus 25 vials — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 55150-0319-25 Eugia 25 ampules — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 68083-0534-25 Gland 25 vials — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 73043-0049-25 Devatis, 25 ampules — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 72205-0191-25 Novadoz 25 vials — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 66794-0250-42 Piramal 25 vials — AP FDA listed —
Chlorpromazine hydrochloride 25 mg/mL 00641-1398-35 Hikma 25 ampules — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 31722-0367-32 Camber 25 vials — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 70771-1779-07 Zydus 25 vials — AP FDA listed —
Chlorpromazine Hydrochloride 25 mg/mL 65219-0130-02 Fresenius 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70771-1778-07 You're viewing this 25 VIAL in 1 CARTON (70771-1778-7) / 1 mL in 1 VIAL (70771-1778-1) 2024-03-29 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70771-1778-7, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70771-1778-07, written without dashes as 70771177807. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70771-1778-07, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1778) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 9 words ▾

No readable label sections were found for this product.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70771-1777-03 · Zydus 70771-1779-07 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.